FDA 510(k)

PASS OCT患者特別な棒

K番号: K153169 · 2016-01-29

決定日2016-01-29

製品コードNKG

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

PASS OCT Patient Specific Rods is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International. It received FDA 510(k) clearance on 2016-01-29 under 510(k) number K153169. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the PASS OCT Patient Specific Rods?

PASS OCT Patient Specific Rods is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is Medicrea International. The 510(k) number is K153169.

When did PASS OCT Patient Specific Rods receive FDA 510(k) clearance?

PASS OCT Patient Specific Rods received FDA 510(k) clearance on 2016-01-29, under 510(k) number K153169.

Who is the listed applicant for PASS OCT Patient Specific Rods?

The FDA 510(k) record lists Medicrea International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PASS OCT Patient Specific Rods?

The FDA product code for PASS OCT Patient Specific Rods is NKG.

申請者としてMedicrea Internationalを記載するその他の記録

K220810Infinity™ OCTシステムおよびPASS OCT脊椎システム K220724CD Horizon™脊椎システムおよびPASS LP™脊椎システム K180091UNiD Spine Analyzer K170172UNiD Spine Analyzer

公式ソース

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